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Effect of Dietary Fiber on Non-dialysis Patients With Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrasumma
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease focused on measuring Dietary fiber, CKD, Anemia, glomerular filtration rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Above 18 years old; Clinically confirmed (history, blood creatinine, kidney B-ultrasound, laboratory examination, etc.) as stage 3-5 chronic kidney disease, endogenous creatinine clearance was < 60ml/min according to Cockcroft-Gault formula; Generally in good condition, have a good understanding of their own illness and physical condition, have self-awareness, and can communicate well with others; Hemoglobin 100-130g/L; In a non-dialysis state. Dietary fiber intake <25g/d; Voluntarily join the study, understand the significance of the test and the indicators to be measured, and sign the informed consent. Exclusion Criteria: Unwilling to join the study; Severe infection: fever, cough and sputum, pharyngeal pain, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/L); Severe cardiovascular diseases: including chronic cardiac insufficiency grade 3 or above and various arrhythmias; Obvious hypoproteinemia: albumin less than 30g/L; Corrective measures for anemia (blood transfusion, erythropoietin, HIF-PHI, iron supplement) have been applied in the past 3 months; Tumor evidence: certain tumors have been detected or clinical manifestations and tumor markers suggest the possibility of tumor; Pregnant women; Recent history of heavy blood loss.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dietary fiber intervention group

    Arm Description

    On the basis of daily diet, dietary fiber supplement (Nutrasumma) was given once a day, 1 strip each time, before meals, and the intervention lasted for 3 months.

    Outcomes

    Primary Outcome Measures

    Changes in baseline hemoglobin levels at 9 months
    Changes of glomerular filtration rate at baseline at 9 months

    Secondary Outcome Measures

    Full Information

    First Posted
    March 19, 2023
    Last Updated
    April 18, 2023
    Sponsor
    Qianfoshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05835648
    Brief Title
    Effect of Dietary Fiber on Non-dialysis Patients With Chronic Kidney Disease
    Official Title
    Effect of Dietary Fiber on Anemia and Glomerular Filtration Rate in Non-dialysis Patients With Chronic Kidney Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 30, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Qianfoshan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective of this study was to investigate the effect of dietary fiber on anemia and glomerular filtration rate in non-dialysis patients with chronic kidney disease. Participants will be randomly divided into a dietary fiber intervention group and a blank control group. The patients in the dietary fiber intervention group will have dietary fiber intake survey conducted by dietitians on the basis of basic treatment. Supplemented dietary fiber was given on the basis of daily diet, once a day, 1 piece each time, before meals, and the intervention lasted for 3 months. The blank control group was followed up without intervention. Clinical data, blood, urine and stool samples were collected at the initial diagnosis and at each follow-up site.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease
    Keywords
    Dietary fiber, CKD, Anemia, glomerular filtration rate

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dietary fiber intervention group
    Arm Type
    Experimental
    Arm Description
    On the basis of daily diet, dietary fiber supplement (Nutrasumma) was given once a day, 1 strip each time, before meals, and the intervention lasted for 3 months.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutrasumma
    Intervention Description
    On the basis of daily diet, dietary fiber supplement (Nutrasumma) was given once a day, 1 strip each time, before meals, and the intervention lasted for 3 months.
    Primary Outcome Measure Information:
    Title
    Changes in baseline hemoglobin levels at 9 months
    Time Frame
    9 months
    Title
    Changes of glomerular filtration rate at baseline at 9 months
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Above 18 years old; Clinically confirmed (history, blood creatinine, kidney B-ultrasound, laboratory examination, etc.) as stage 3-5 chronic kidney disease, endogenous creatinine clearance was < 60ml/min according to Cockcroft-Gault formula; Generally in good condition, have a good understanding of their own illness and physical condition, have self-awareness, and can communicate well with others; Hemoglobin 100-130g/L; In a non-dialysis state. Dietary fiber intake <25g/d; Voluntarily join the study, understand the significance of the test and the indicators to be measured, and sign the informed consent. Exclusion Criteria: Unwilling to join the study; Severe infection: fever, cough and sputum, pharyngeal pain, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/L); Severe cardiovascular diseases: including chronic cardiac insufficiency grade 3 or above and various arrhythmias; Obvious hypoproteinemia: albumin less than 30g/L; Corrective measures for anemia (blood transfusion, erythropoietin, HIF-PHI, iron supplement) have been applied in the past 3 months; Tumor evidence: certain tumors have been detected or clinical manifestations and tumor markers suggest the possibility of tumor; Pregnant women; Recent history of heavy blood loss.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Dietary Fiber on Non-dialysis Patients With Chronic Kidney Disease

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